Evidence map›Paper›PMID 32889792›Full record

Trial reportInfluenza and other respiratory viruses2021

Non-neutralizing antibody responses following A(H1N1)pdm09 influenza vaccination with or without AS03 adjuvant system.

Damien Friel, Mary Co, Thierry Ollinger, Bruno Salaun, Anne Schuind, Ping Li, Karl Walravens, Francis A Ennis, David W Vaughn

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Influenza and other respiratory viruses, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00985673 (A Study to Evaluate the Safety and Immunogenicity of an A/California/7/2009), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.9field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00985673 phase2completednot on this map

A Study to Evaluate the Safety and Immunogenicity of an A/California/7/2009 (H1N1)V-like Vaccine GSK2340274A or GSK2340273A Co-administered With Trivalent Inactivated Seasonal Influenza Vaccine in Adults 19 to 40 Years of Age

TypeinterventionalSponsorGlaxoSmithKlineRan2009 to 2010Enrolled611ConditionsInfluenzaArmsGSK2340274A, GSK2340273A, Seasonal trivalent influenza vaccine (TIV), Saline placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 2 countries.

Damien FrielGSK, Wavre, Belgium.ORCID 0000-0001-7284-8949
Mary CoUniversity of Massachusetts Medical School, Worcester, MA, USA.
Thierry OllingerGSK, Wavre, Belgium.ORCID 0000-0001-9964-0152
Bruno SalaunGSK, Rixensart, Belgium.ORCID 0000-0002-8927-8660
Anne SchuindGSK, Rockville, MD, USA.ORCID 0000-0003-3544-0682
Ping LiGSK, King of Prussia, PA, USA.ORCID 0000-0001-6328-036X
Karl WalravensGSK, Wavre, Belgium.ORCID 0000-0003-1665-2604
Francis A EnnisUniversity of Massachusetts Medical School, Worcester, MA, USA.
David W VaughnGSK, Rockville, MD, USA.ORCID 0000-0002-1396-1690
GlaxoSmithKline (Belgium) · BEGlaxoSmithKline (United States) · USUniversity of Massachusetts Chan Medical School · USDE Technologies (United States) · US

Funding

Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority HHSO100200700029C
6 · The paper itself

Abstract

backgroundNon-neutralizing antibodies inducing complement-dependent lysis (CDL) and antibody-dependent cell-mediated cytotoxicity (ADCC) activity may contribute to protection against influenza infection. We investigated CDL and ADCC responses in healthy adults randomized to receive either non-adjuvanted or AS03-adjuvanted monovalent A(H1N1)pdm09 vaccine (containing 15 µg/3.75 μg of hemagglutinin, respectively) on a 2-dose schedule 21 days apart.

methodsWe conducted an exploratory analysis of a subset of 106 subjects having no prior history of A(H1N1)pdm09 infection or seasonal influenza vaccination enrolled in a previously reported study (NCT00985673). Antibody responses against the homologous A/California/7/2009 (H1N1) vaccine strain and a related A/Brisbane/59/2007 (H1N1) seasonal influenza strain were analyzed up to Day 42.

resultsBaseline seropositivity determined with hemagglutination inhibition (HI), CDL and ADCC antibody titers against viral strains was high; A/California/7/2009 (HI [40.4-48.1%]; CDL [34.6-36.0%]; ADCC [92.1-92.3%]); A/Brisbane/59/2007 (HI [73.1-88.9%]; CDL [38.0-42.0%]; ADCC [86.8-97.0%]). CDL seropositivity increased following vaccination with both adjuvanted and non-adjuvanted formulations (A/California/7/2009 [95.9-100%]; A/Brisbane/59/2007 [75.5-79.6%]). At Day 21, increases in CDL and ADCC antibody geometric mean titers against both strains were observed for both formulations. After 2 doses of AS03-adjuvanted vaccine, vaccine responses of 95.8% (≥9-fold increase from baseline in CDL titers) and 34.3% (≥16-fold increase from baseline in ADCC titers) were seen against A/California/7/2009; and 22.4% and 42.9%, respectively, against A/Brisbane/59/2007. Vaccine responses after 2 doses of the non-adjuvanted vaccine were broadly similar.

conclusionsBroadly comparable non-neutralizing immune responses were observed following vaccination with non-adjuvanted and AS03-adjuvanted A(H1N1)pdm09 formulations; including activity against a related vaccine strain.

Indexed as

Influenza A Virus, H1N1 SubtypeInfluenza, HumanInfluenza VaccinesAdjuvants, ImmunologicAntibodies, ViralHemagglutination Inhibition TestsHumansPolysorbatesSqualeneVaccinationAdjuvants, ImmunologicAntibodies, ViralInfluenza VaccinesPolysorbatesSqualeneA(H1N1)pdm09 vaccineAS03 adjuvant systemcross-reactivitynon-neutralizing antibodies

Identifiers

PMID32889792
PMCPMC7767944
OpenAlexW3083168270

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.